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Topics in Pharmaceutical Science

  • Module code: CH6009
  • Year: 2018/9
  • Level: 6
  • Credits: 30
  • Pre-requisites: None
  • Co-requisites: None

Summary

This module is a core module for the Pharmaceutical Science BSc and Integrated Masters courses. This module aims to address the need for a synoptic/capstone module which draws the whole course together.  It introduces various aspects of chemical and pharmaceutical industry pertinent to their future career and aims to cover a wide range of topics covering Drug Delivery, Polymers and Biomaterials, patents, intellectual property, health and safety, and legislation.  Many of the descriptive parts of the module are reinforced by workshops and group debate to develop their communication, teamwork and independent learning skills. There are also lectures, workshops and practical sessions to demonstrate and reinforce the concept learnt.

Aims

  • To provide an understanding of the development of the chemical and pharmaceutical industry, its consequent structure and nature.
  • To develop a deeper understanding of specific sectors of the industry in particular the drug delivery in the pharmaceutical formulations.
  • To introduce macromolecules and biomaterials as part of such drug delivery systems by taking them through each step from synthesis, properties to final product.
  • To critically assess the purpose, design, manufacture, and in-process tests for a more advanced pharmaceutical formulations- to ensure patient acceptability and efficacy in clinical use.
  • To introduce aspects of operation of the industry such as patents and licences, health and safety, and quality assurance.

Learning outcomes

On successful completion of the module, students will be able to:

  • Discuss specialised dosage forms e.g. drug-device combinations, sterile implants, transdermal patches, etc.
  • Evaluate the issues affecting drug substance and drug product stability, including justification of packaging systems chosen as well as decomposition and drug-excipient interactions.
  • Appraise the function of in-process testing, operational ranges and limits set for analyses during production, batch release, and shelf-life studies.
  • Describe the basic chemistry of polymers and discuss the range of physical and chemical properties which may be needed in commercial polymers and biomaterials, and describe how the required properties can be realised by choosing appropriate materials and processing in biomedical and industrial applications such as drug delivery, ophthalmology and medical prosthetics.
  • Fully understand the complex nature and structure of the chemical and pharmaceutical industry and understand how management and operational aspects of the industry is implemented, including patents and licences, legislation, health and safety, ethics and quality assurance.

Curriculum content

  • Identifying the ideal characteristics for a range of novel pharmaceutical designs such as stability of drugs.
  • The discipline of particulate science and effects on granulation. Methods of crystal engineering, and effects on macromolecules' stability.
  • Overview of polymerisation reactions; biochemical routes to natural and synthetic polymers. Outline principles of the environmental degradation of polymers.
  • Synthetic polymers for biomedical applications: e.g. ophthalmic, prosthetics and dentistry as well as drug delivery. Hydrogels, e.g. for tissue culture media or soft contact lenses.
  • The structure of the chemical and pharmaceutical industry. marketing of chemicals, patents and licences, health and safety, quality assurance and control.

Teaching and learning strategy

This module is delivered through a variety of lectures, workshops and practical laboratory sessions. Three concurrent series of lectures (15 each) will be used to deliver the core material.  The lecture course will identify key topics for development and supplementary workshops will be used to investigate and pursue the more conceptually demanding aspects of the syllabus. Laboratory sessions have been designed to augment the theoretical aspects of the course and have been arranged such that they complement different topics. Each workshop is designed and sometimes assessed to give them a quick feedback and to encourage regular attendance and self assessment.  Also there is a debate session per group focussing on topical issues touching on morals and ethics past examples included Bhopal accident,  Use of Thalidomide, legalisation of Cannabis.  This is aimed at addressing the employability skills such as independent thinking, gathering information and presentation skills as well as learning to work as a team. 

Breakdown of Teaching and Learning Hours

Definitive UNISTATS Category Indicative Description Hours
Scheduled learning and teaching 45 one hour lectures 24 hours of workshops 7 x 3 hour practical classes 90
Guided independent study Recommended reading Formative assessment Summative assessment tasks Exam revision 210
Total (number of credits x 10) 300

Assessment strategy

An independent group exercise will be taken as part of the summative assessment to expand students' development of key skills such as group working, communication and information retrieval. This capstone type new assessment is intended to encourage students to gain and improve skills important to their future employability such as entrepreneurship and creativity as well as developing communications skills, critical thinking, presentation skills and objective setting. Practical performance and reporting skills will be partially assessed by evaluation of the quality of samples and data obtained using online feedback during the class.  This should assist students to get relevant feedback on their practical skills to act as feed forward for their summatively assessed work in future. Further formative workshop sessions will provide the students with informal exposure to skills needed in employment. The 3-hour exam will require students to do four long answer questions concerning polymers with specialised applications of them, and drug delivery and pharmaceutics.

Mapping of Learning Outcomes to Assessment Strategy (Indicative)

Learning Outcome Assessment Strategy
1) Discuss specialised dosage forms e.g. drug-device combinations, sterile implants, transdermal patches, etc. Formative assessment opportunity will be provided via workshop sessions, summative assessment via practical and section of examination paper.
2) The discipline of particulate science and effects on granulation. Methods of crystal engineering, and effects on macromolecules' stability. Formative assessment opportunity will be provided via workshop sessions, summative assessment via section of examination paper.
3) Appraise the function of in-process testing, operational ranges and limits set for analyses during production, batch release, and shelf-life studies. Formative assessment opportunity will be provided via workshop sessions and summative assessment via section of examination paper.
4) Describe the basic chemistry of polymers and discuss the range of physical and chemical properties which may be needed in commercial polymers and biomaterials, and describe how the required properties can be realised by choosing appropriate materials and processing in biomedical and industrial applications such as drug delivery, ophthalmology and medical industry Formative and summative assessment opportunity will be provided via workshop sessions and via section of examination paper, as well as summatively assessed practical portfolio.
5) Fully understand the complex nature and structure of the chemical and pharmaceutical industry and understand how management and operational aspects of the industry is implemented, including patents and licences, legislation, health and safety, ethics and quality assurance Formative assessment opportunity will be provided via workshop sessions and via section of examination paper. There will also be assessment through an assignment to bring the whole module together.

Elements of Assessment

Description of Assessment Definitive UNISTATS Categories Percentage
Formal 3 hour examination Written Exam 50%
7 x 5% of portfolio of polymer and drug delivery practical e.g. sample, data analysis Coursework 35%
Capstone assessment with group work assessed as final presentation with final report covering e.g. role of various departments in fictitious chemical/ pharmaceutical company, novel materials, research strategies. Coursework 15%
Total (to equal 100%) 100%

Achieving a pass

It IS NOT a requirement that any major element of assessment is passed separately in order to achieve an overall pass for the module.

Bibliography core texts

Drug Delivery

Core Text(s):

Pharmaceutics: the Design and Manufacture of Medicines; Michael E Aulton (ed.);

Churchill Livingston; Latest Edition.

Polymers and Biomaterials

Core Texts:

Cowie, J M G and Arrighi, V, Polymers: Chemistry and Physics of Modern Materials Latest Edition

Dumitriou, S (ed.), Polymeric Biomaterials (2nd Edn., Marcel Dekker, 2002)

Bibliography recommended reading

Drug Delivery

Recommended Reading:

The Physicochemical Basis of Pharmaceutics; H Moynihan & A Crean; Oxford University Press, Latest Edition

FASTtrack: Pharmaceutics - Dosage Form and Design, David Jones, Pharmaceutical Press, London; latest edition.

British Pharmacopoeia; B.P. Commission Secretariat of the Medicines and Healthcare products Regulatory Agency & The Stationery Office, London; latest edition.

Polymers and Biomaterials

Recommended Reading:

Billmeyer, F W A Textbook of Polymer Science, Latest Edition

Young, R J and Lovell, PA  Introduction to Polymers Latest Edition

Saunders, K Organic Polymer Chemistry Latest Edition

Biomaterials (Journal, Elsevier; available on-line): recommended articles and general  reference.

Medicinal Chemistry and Drug Discovery, 2nd Ed, Surley M. D. J Wiley Pharmacy Law and Practice, J Merrilles and J Fisher, Slackwell Science

Fine Chemicals Manufacture, Technology, and Engineering, ACybulski, J A Moulijn, M Sharma, Elsevier 2001

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